Prescription medicine
Pegulicianine Brand names: Lumisight
Pegulicianine (Lumisight) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pegulicianine FDA label on DailyMed (effective January 9, 2026, Lumicell, Inc.); the NDA 214511 record on Drugs@FDA; every pegulicianine label on DailyMed.
Highlights of the record
FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS.
Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration of LUMISIGHT. Anaphylaxis occurred in 4/726 (0.6%) of patients in clinical studies. Signs and symptoms associated with other hypersensitivity reactions included pruritus, urticaria, hypotension, lip swelling, erythema, anxiety, chest pain, cyanosis, dizziness, dyspnea, headache, hypoesthesia, hyperventilation, maculopapular rash, nausea, paresthesia, visual changes, and vomiting. Before LUMISIGHT administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). Always have emergency resuscitation drugs, equipment, and trained personnel promptly available. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. LUMISIGHT is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine [see Warning and Precautions (5.1) ]. WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration. […]
Used for
From the label: indications and usageLUMISIGHT is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
Forms and strengths
- 10 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- April 17, 2024 Lumisight, Lumicell; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 14, 2034 Lumisight injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5 through July 30, 2026
What is pegulicianine used for?
From the label: indications and usageLUMISIGHT is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. LUMISIGHT is an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
Source: FDA drug label (LUMISIGHT), Lumicell, Inc., effective January 9, 2026 (SPL set 7160e774-663a-43e4-ba4a-06cc57830e66), via openFDA; the full label on DailyMed
Is there a generic for pegulicianine (Lumisight)?
No generic pegulicianine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Lumisight injection: the compound patent runs to September 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pegulicianine?
The FDA Adverse Event Reporting System holds 5 reports that list pegulicianine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pegulicianine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other